BRIDGEWATER, New Jersey—The US Food and Drug Administration (FDA) has approved Taxotere (docetaxel, Aventis) as first-line therapy, in combination with cisplatin(Drug information on cisplatin) (Platinol), in patients with unresectable, locally advanced or metastatic non-small-cell lung cancer (NSCLC).
Taxotere is the only agent indicated both for patients with newly diagnosed NSCLC, in combination with cisplatin, and for those with previously treated advanced NSCLC, as a single agent, Aventis said in a news release announcing the approval.
The FDA approval was based on a randomized controlled international phase III trial of 1,218 good performance status patients with previously untreated advanced NSCLC. Patients were randomized to receive Taxotere/cisplatin, Taxotere/carboplatin (Paraplatin), or a standard regimen of vinorelbine (Navel-bine)/cisplatin.
Patients in the Taxotere/cisplatin arm had a median survival of 10.9 months vs 10 months for vinorelbine/cisplatin (P = .035). The overall response rates were 31.6% for Taxotere/cisplatin vs 24.4% for vinorelbine/cisplatin. The Taxotere/carboplatin combination produced survival and response rates similar to those seen with vinorelbine/cisplatin.
Additional study analysis showed that the benefits from Taxotere/cisplatin were maintained in patients who were 65 years of age and older. This age group accounts for 68% of all lung cancer patients, according to data from the National Cancer Institute. Taxotere/cisplatin also showed clinical benefits in maintaining body weight, performance status, and pain management, compared with vinorelbine/cisplatin.
